Assyro AI

Orange Book product · Generic (ANDA)

QUETIAPINE FUMARATE

QUETIAPINE FUMARATE

Generic (ANDA)ANDA 206954TE ABRX PRINSTON INC

At a glance

Aug 24, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 24, 2022

    3 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

QUETIAPINE FUMARATE

Strength

EQ 25MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 206954

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of QUETIAPINE FUMARATE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.